Reagila 3 mg. 28 capsules

What Reagila is and what it is used for
Reagila contains the active substance cariprazine, which belongs to a group of medicines called antipsychotics. It is used to treat adults with schizophrenia.

Schizophrenia is a disease that is characterized by symptoms such as hearing, seeing or feeling things that are not there (hallucinations), suspiciousness, mistaken beliefs, incoherent speech, behavioral and emotional flattening.

People with this disorder may also feel depressed, feel guilty, anxious, tense, or unable to start or finish planned actions, be unwilling to talk, have a lack of emotional response in a situation that evokes emotions in other people .

2. What you need to know before you take Reagila
Do not take Reagila:
if you are allergic to cariprazine or any of the other ingredients of this medicine (listed in section 6).
if you are taking medicines used to treat:
hepatitis caused by the hepatitis C virus (medicines containing boceprevir and telaprevir);
bacterial infections (medicines containing clarithromycin, telithromycin, erythromycin and nafcillin);
tuberculosis (medicines containing rifampicin)
HIV infection (medicines containing cobicistat, indinavir, nelfinavir, ritonavir, saquinavir, efavirenz and etravirine)
fungal infections (medicines containing intraconazole, posaconazole, voriconazole and fluconazole);
Cushing's syndrome - when the body produces an excess amount of cortisol (medicines containing ketoconazole)
depression (treatment with herbs containing St. John's wort (Hypericum perforatum) and drugs containing nefazodone);
epilepsy and seizures (medicines containing carbamazepine, phenobarbital and phenytoin);
heart disease (medicines containing diltiazem and verapamil)
drowsiness (medicines containing Modafinil);
increased blood pressure in the lungs (medicines containing bosentan).
Warnings and precautions
Consult your doctor immediately:
if you think or feel that you are going to harm or kill yourself. Suicidal thoughts and suicide attempts are more likely at the beginning of treatment.
if you have a combination of fever, sweating, rapid breathing, muscle stiffness, dizziness or sleepiness (these may be signs of neuroleptic malignant syndrome).
Consult your doctor or pharmacist before taking Reagila or during treatment if:
have ever experienced or start to experience restlessness or inability to stand still. These symptoms may appear soon after starting treatment with Reagila. Tell your doctor if this happens;
you have ever had or now have unusual, involuntary movements, mainly of the tongue or face. Tell your doctor if this happens.
visual impairment. Your doctor will advise you to consult an ophthalmologist;
You have or someone in your family has had a heart rhythm disorder (including so-called QT prolongation seen on an ECG), tell your doctor if you are taking other medicines, as they may cause or worsen this change in EKG;
you have high or low blood pressure, you have cardiovascular disease. Your doctor will need to check your blood pressure regularly;
you feel dizzy when you stand up due to a sudden drop in blood pressure, which can lead to fainting;
You or someone in your family has had blood clots in the past, as medicines for schizophrenia are associated with blood clots;
You or someone in your family has had blood clots in the past, as medicines for schizophrenia are associated with blood clots;
you have had a stroke, especially if you are elderly or know you have other risk factors for stroke. Tell your doctor right away if you notice any signs of a stroke;
you have dementia (memory loss and other mental problems) especially if you are elderly;
you have Parkinson's disease;
if you have diabetes or risk factors for diabetes (eg obesity or a close relative with diabetes). Your doctor will check your blood sugar regularly as it may increase while taking Reagila.
Signs of high blood sugar levels are excessive thirst, passing large amounts of urine, increased appetite and feeling weak;

you have had seizures (fits) or epilepsy in the past.
Weight gain
Reagila can cause significant weight gain, which can affect your health. Therefore, your doctor will regularly check your weight.

Children and adolescents
This medicine is not recommended for use in children and adolescents under the age of 18 due to a lack of data in such patients.

Other medicines and Reagila
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. You should not take certain medicines together with Reagila (see section "Do not take Reagila").

When Reagila is taken together with certain medicines, it may be necessary to adjust the dose of Reagila or the dose of the other medicines. These are medicines used to treat heart disease containing digoxin, blood thinners containing dabigatran or medicines that affect mental function.

Reagila with food, drink and alcohol
You should not consume grapefruit juice during treatment with Reagila.
Alcohol consumption should be avoided while taking Reagila.

Pregnancy and breastfeeding
Women of childbearing potential/contraception

Women of childbearing potential should use effective contraception during treatment with Reagila. Even after stopping treatment, contraception should be used for at least 10 weeks after taking the last dose of Reagila. The reason is that the medicine stays in your body for some time after taking the last dose.

Pregnancy
Do not take this medicine during pregnancy unless directed by your doctor.

If your doctor decides that you should take this medicine during pregnancy, he will monitor your baby after birth, as the following symptoms may occur in newborn babies whose mothers have taken this medicine in the last trimester (last three months) from pregnancy:

- tremors, muscle stiffness and/or weakness, drowsiness, overexcitement, breathing problems, difficulty eating.

If your baby develops any of these symptoms, you should contact your doctor.

Breastfeeding
You should not breastfeed while taking Reagila, as a risk to the baby cannot be excluded. Consult your doctor.

Driving and using machines
There is a minimal or moderate risk that this medicine may affect the ability to drive and use machines. During treatment you may experience drowsiness, dizziness and vision problems (see section 4). Do not drive or operate tools or machines until you know if this medicine affects you adversely.

Reagila 3 mg, 4.5 mg, 6 mg hard capsules contain Allura red AC (E 129).

Allura Red AC is a dye that can cause allergic reactions.

3. How to take Reagila

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

The recommended starting dose is 1.5 mg taken orally once daily. Your doctor may then gradually adjust your dose in 1.5 mg increments depending on how the treatment is working for you.

The maximum daily dose should not exceed 6 mg.

Take Reagila at the same time each day, with or without food.

If you are taking another medicine for schizophrenia before you start taking Reagila, your doctor will decide whether to stop taking the other medicine for schizophrenia gradually or immediately and what the dose of Reagila should be. Your doctor will also tell you what to do if you switch from Reagila to another medicine.

Patients with kidney or liver problems
If you suffer from serious kidney or liver problems, Reagila may not be suitable for you. Consult your doctor.

Old age
Your doctor will carefully choose the right dose for you.

Reagila should not be taken by elderly patients with dementia (memory loss).

If you take more Reagila than you should
If you have taken more Reagila than your doctor prescribed, or for example a child has taken Reagila by mistake, contact your doctor or go to the nearest hospital straight away by
Very common side effects (may affect more than 1 in 10 people)
feeling restless and unable to stay still
parkinsonism - a disease with many different symptoms that include reduced or slowed movements, slowed thought process, convulsions when limbs are flexed (cogwheel-type rigidity), leg dragging, tremors, reduced or absent change in facial expression, stiffness of the muscles, drooling
Common side effects (may affect up to 1 in 10 people)
anxiety
drowsiness, difficulty falling asleep, unusual dreams, nightmares, sleepwalking
dizziness
involuntary twisting movements and strange postures
excessive teeth grinding or jaw clenching, drooling, constant blinking in response to tapping on the forehead (an abnormal reflex), motor problems, impaired tongue movement (these are called extrapyramidal symptoms)
blurred vision
high blood pressure
fast, irregular pulse
decreased or increased appetite
nausea, vomiting, constipation
increased body weight
fatigue
the following side effects may be observed in laboratory tests:
elevated liver enzymes
increased levels of creatine phosphokinase in the blood ° abnormal levels of lipids (eg cholesterol and/or fat) in the blood
Uncommon side effects (may affect up to 1 in 100 people)
depression
sudden and intense confusion
feeling dizzy
unpleasant, unusual sensation to the touch
dizziness, lack of energy, or lack of interest in doing activities
involuntary movements, most often of the tongue or face. This can happen after short or long-term use of the drug.
decreased or increased sexual desire, erection problems
eye irritation, increased pressure in the eye, impaired vision
trouble focusing when looking far or near
low blood pressure
deviations in ECG results, abnormal nerve impulses in the heart
slow, irregular heartbeat
hiccups
stomach acids
thirst
pain when urinating
unusual frequency of urination and volume of urine passed
itching, rash
diabetes
the following adverse reactions may be observed in the results of laboratory tests:
abnormal levels of sodium in the blood
increased levels of glucose in the blood (blood sugar), increased bile pigment (bilirubin) in the blood
anemia (reduced number of red blood cells)
increased levels of a type of white blood cell
decreased level of thyroid stimulating hormone (TSH) in the blood
Rare side effects (may affect up to 1 in 1,000 people)
convulsions
memory loss, loss of speech
eye discomfort in bright light
clouding of the lens of the eye leading to reduced vision (cataract)
difficulty swallowing
decreased levels of a type of white blood cell, which can make you more susceptible to infections
reduced thyroid function
Not known (frequency cannot be estimated from the available data)
inflammation of the liver (pain in the upper right part of the abdomen, yellowing of the eyes and skin, weakness, fever)
5. How to store Reagila
Keep out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP and EXP. The expiration date corresponds to the last day of the specified month.

Keep the blister in the carton in order to protect from light.

This medicine does not require special temperature storage conditions.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information
What Reagila contains
The active substance is cariprazine.
Reagila 1.5 mg: each hard capsule contains cariprazine hydrochloride equivalent to 1.5 mg cariprazine.

Reagila 3 mg: each hard capsule contains cariprazine hydrochloride equivalent to 3 mg cariprazine.

Reagila 4.5 mg: each hard capsule contains cariprazine hydrochloride equivalent to 4.5 mg cariprazine.

Reagila 6 mg: each hard capsule contains cariprazine hydrochloride equivalent to 6 mg cariprazine.

The other ingredients are:
Reagila 1.5 mg hard capsules: pregelatinized (maize) starch, magnesium stearate, titanium dioxide (E 171), gelatin, black printing ink (shellac, black iron oxide (E 172), propylene glycol, potassium hydroxide).

Reagila 3 mg hard capsules: pregelatinized (maize) starch, magnesium stearate, allura red AC (E 129), brilliant blue FCF (E 133), titanium dioxide (E 171), yellow iron oxide (E 172), gelatin, black printed ink (shellac, black iron oxide (E 172), propylene glycol, potassium hydroxide) (See also point 2).

Reagila 4.5 mg hard capsules: pregelatinized (maize) starch, magnesium stearate, allura red AC (E 129), brilliant blue FCF (E 133), titanium dioxide (E 171), yellow
Reagila 6 mg hard capsules: pregelatinized (maize) starch, magnesium stearate, brilliant blue FCF (E 133), allura red AC (E 129), titanium dioxide (E 171), gelatin, black printing ink (shellac, black iron oxide ( E 172), propylene glycol, potassium hydroxide).

What Reagila looks like and contents of the pack
Reagila 1.5 mg hard capsules: size 4 hard gelatin capsule (approximately 14.3 mm in length) with a white opaque cap and white opaque body, with “GR 1.5” printed in black ink on the capsule body. The capsules are filled with a white to yellowish-white powdery mixture.
Reagila 3 mg hard capsules: hard gelatin capsule, size 4 (approximately 14.3 mm long) with a green opaque cap and a white opaque body, with “GR 3” printed in black ink on the capsule body. The capsules are filled with a white to yellowish-white powdery mixture.
Reagila 4.5 mg hard capsules: size 4 hard gelatin capsule (approximately 14.3 mm in length) with a green opaque cap and green opaque body, with “GR 4.5” printed in white ink on the capsule body. The capsules are filled with a white to yellowish-white powdery mixture.
Reagila 6 mg hard capsules: size 3 hard gelatin capsule (approximately 15.9 mm in length) with a violet opaque cap and a white opaque body, with “GR 6” printed in black ink on the capsule body. The capsules are filled with a white to yellowish-white powdery mixture.
The capsules are packed in a transparent rigid PVC/PE/PVDC blister, heat-sealed with a rigid aluminum foil. The blisters are packed in a cardboard box.

Reagila 1.5 mg and Reagila 3 mg hard capsules are available in packs containing 7, 14, 21, 28, 30, 49, 56, 60, 84, 90 or 98 hard capsules.

Reagila 4.5 mg and Reagila 6 mg hard capsules are available in packs containing 7, 21, 28, 30, 49, 56, 60, 84, 90 or 98 hard capsules.

Not all types of packaging can be put on sale.

 

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